Oncology FDA Approval– category –
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Oncology Drug Approval News Flash: Vimseltinib (Romvimza) Approved by FDA for Tenosynovial Giant Cell Tumor (TGCT)
【FDA Approval Alert】Deciphera's vimseltinib (Romvimza) Approved for TGCT (February 14, 2025) On February 14, 2025, the U.S. FDA approved vimseltinib (Romvimza) for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) wh... -
Oncology Drug Approval News Flash: Brentuximab Vedotin + Lenalidomide + Rituximab Combination Receives Accelerated FDA Approval for R/R LBCL
【FDA Approval Alert】Seagen's brentuximab vedotin combination Approved for Relapsed/Refractory Large B-Cell Lymphoma (LBCL) (February 11, 2025) On February 11, 2025, the U.S. FDA granted accelerated approval to brentuximab vedotin (Adce... -
Oncology Drug Approval News Flash: Mirdametinib (Gomekli) Approved by FDA for NF1-Associated Plexiform Neurofibromas
【FDA Approval Alert】SpringWorks's mirdametinib (Gomekli) Approved for NF1-Associated Plexiform Neurofibromas (February 11, 2025) On February 11, 2025, the U.S. FDA approved mirdametinib (Gomekli) for patients aged 2 years and older wit... -
Oncology Drug Approval News Flash: Fam-trastuzumab deruxtecan-nxki (Enhertu) Approved by FDA for HER2-Low and Ultralow Breast Cancer
【FDA Approval Alert】Daiichi Sankyo's Enhertu Approved for HER2-Low and Ultralow Breast Cancer (January 27, 2025) On January 27, 2025, the U.S. FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adults with unresectable or metas... -
Oncology Drug Approval News Flash: Datopotamab Deruxtecan-dlnk (Datroway) Approved by FDA for HR-Positive, HER2-Negative Breast Cancer
【FDA Approval Alert】Daiichi Sankyo's Datroway Approved for HR-Positive, HER2-Negative Breast Cancer (January 17, 2025) On January 17, 2025, the U.S. FDA approved datopotamab deruxtecan-dlnk (Datroway) for adults with unresectable or me...
